A randomised, placebo-controlled, single-centre, double-blind study to evaluate the efficacy, safety and tolerability of topically applied piroxicam gel in patients with recurrent herpes labialis

• Conditions: Recurrent Herpes labialis; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003239-31-DE
• Lead Sponsor: HOV GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-19
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. females and males, at least 18 years of age,
2. written signed informed consent form,
3. at least 3 herpes labialis recurrencies during the past 12 months, but otherwise in good general health,
4. a history of prodromal symptoms during more than 50% of prior herpes labialis episodes (tingling, tenderness, pain, burning, itching, sensation of tension),
5. a history of more than 50% of the herpes labialis episodes producing classical lesions (i. e. vesicles, ulcers, and/or a hard crust)
6. recurrent herpes labialis in the prodromal or erythema stage reported at Visit 1 (day 0).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. patients with alcohol or drug-abuse
2. pregnant or lactating women
3. women who plan to get pregnant during the time of the study
4. women of childbearing age who do not use a highly effective method of contraception (contraceptive measures with a Pearl index < 1 are considered highly effective)
5. known hypersensitivity to piroxicam, to any excipient of the study medication or to other analgesics or antirheumatics (non-steroidal anti-inflammatory drugs)
6. current participation in another study with an investigational drug or within 30 days Prior to the Screening Visit;
7. patients who receive any anti-viral medication;
8. patients with renal function impairments chronic obstructive pulmonary disease
9. patients with medical or psychiatric conditions which may pose a risk to the patient in this study or adversely interact with relevant study measures or the patient’s ability to participate in the study according to the investigator´s judgment
10. evidence of an uncooperative attitude or known or suspected inability to comply with the clinical study protocol
11. patients who are institutionalised due to a regulatory action or court order
12. if more than 12 hours have passed since the onset of the prodromal herpes labialis symptoms before Visit 1 (day 0)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified